Alkermes reports Phase 1 data for ALKS 2680 showing significant sleep latency improvement in narcolepsy type 1

Alkermes plc.

ALKS 2680 demonstrated dose-dependent improvement in sleep latency: +18, +30, +37 minutes vs placebo (-1 min) at 1, 3, 8 mg (p<0.01 to p<0.001).
At 8 mg dose, patients maintained wakefulness for full 40-minute MWT up to 10 hours post-dose.
ALKS 2680 generally well tolerated; mild AEs at 8 mg (insomnia, pollakiuria, salivary hypersecretion); no serious AEs.
PK profile supports once-daily oral dosing; Phase 2 study planned for H1 2024.
First cohort (4 NT1 patients) data presented at World Sleep Congress; study also enrolling NT2 and IH patients.

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